Praxis

Senior Manager, Analytical Development

Praxis

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $140,000 - $160,000 per year

Job Level

Senior

About the role

  • Involved in supporting analytical deliverables of the CMC programs while working in conjunction with CMC team members.
  • Management of analytical testing in our external network, especially as it relates to GMP drug substances and drug products.
  • Ensuring that analytical documentation (protocols, reports, methods, COAs, change controls, etc.) are added contemporaneously to Praxis’ document management system.
  • Oversight and coordination of CMC stability and reference standard programs.
  • Direct monitoring of our external network providers that execute Analytical Development activities to ensure deliverables and continuously improve efficiency.
  • Supporting the design and development of phase-appropriate quality control strategies, specifications, and stability studies for drug substance and drug product.
  • Contribute to the overall CMC team in terms of execution.
  • Collaborate with other functions of Praxis CMC to establish the technical and business practices of the team.

Requirements

  • Bachelor’s degree in Analytical Chemistry or related discipline with 10+ years of industry experience; Master’s degree or equivalent a plus.
  • Industry experience in Analytical Development specifically for small molecule drug substance as well as solid and liquid oral drug products is required.
  • Strong attention to detail along with the ability to perform meticulous data review and data transcription review.
  • Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.
  • Ability to interpret and implement, as appropriate, compendia-based testing requirements for drug substances and drug products.
  • Involvement in reference standard management and stability oversight.
  • Experience with CMC development and support across all phases of drug development from initial regulatory filings through registration, validation and launch preferred.
  • Experience in support of late stage / commercial products including product monitoring, improvement and issue resolution preferred.
  • Demonstrated success in building and maintaining productive partnerships with CDMO partners and associated service providers.
  • Fluid and conversant with GMP and quality control.
  • Demonstrates a high level of intellectual curiosity, innovation, and creative problem solving with an entrepreneurial spirit.
  • Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms.
  • Highly organized and detail-oriented with a passion to deliver quality results.
Benefits
  • 99% of the premium paid for medical, dental and vision plans.
  • Company-paid life insurance, AD&D, disability benefits.
  • Voluntary plans to personalize your coverage.
  • 401(k) match dollar-for-dollar up to 6% on eligible contributions.
  • Long-term stock incentives and ESPP.
  • Discretionary quarterly bonus.
  • Flexible wellness benefit.
  • Generous PTO, paid holidays and company-wide shutdowns.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
analytical chemistrydata reviewdata transcriptioncGMP requirementscompendia-based testingreference standard managementstability oversightquality control strategiesanalytical testingCMC development
Soft Skills
attention to detailinterpersonal skillscommunication skillsorganizational skillsproblem solvinginnovationintellectual curiosityrelationship buildingteam collaborationpassion for quality results